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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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December 22, 2009

GE Healthcare's Idiotic Libel Suit

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Posted by Derek

Courtesy of Pharmalot (and my mail!), I note this alarming story from London. GE Healthcare makes a medical NMR contrast agent, a gadolinium complex marketed under the name of Omniscan. (They picked it up when they bought Amersham a few years ago). Henrik Thomsen, a Danish physician had noted what may be an association with its use and a serious kidney condition, nephrogenic systemic fibrosis, and he gave a short presentation on his findings two years ago at a conference in Oxford.

For which GE is suing him. For libel. Update: the documents of the case can be found here. They claim that his conference presentation was defamatory, and continue to insist on damages even though regulatory authorities in both the UK and in the rest of Europe have reviewed the evidence and issued warnings about Omniscan's use in patients with kidney trouble. Over here in the US, the FDA had issued general advisories about contrast agents, but an advisory panel recently recommended that Omniscan (and other chemically related gadolinium complexes) be singled out for special warnings. From what I can see, Thomsen should win his case - I hope he does, and I hope that he gets compensatory damages from GE for wasting his time when he could have been helping patients.

And this isn't the only case going on there right now. Author Simon Singh is being sued by the British Chiropractic Association for claiming in a published article that chiropractic claims of being able to treat things like asthma as "bogus". Good for him! But he's still in court, and the end is not in sight.

This whole business is partly a function of the way that GE and the chiropractors have chosen to conduct business, but largely one of England's libel laws. The way things are set up over there, the person who brings suit starts out with a decided edge, and over the years plenty of people have taken advantage of the tilted field. There's yet another movement underway to change the laws, but I can recall others that apparently have come to little. Let's hope this one succeeds, because I honestly can't think of a worse venue to settle a scientific dispute than a libel suit (especially one being tried in London).

So, General Electric: is it now your company policy to sue people over scientific presentations that you don't like? Anyone care to go on record with that one?

Comments (40) + TrackBacks (0) | Category: Analytical Chemistry | Current Events | The Dark Side | Toxicology


COMMENTS

1. leftscienceawhileago on December 22, 2009 11:26 AM writes...

The UK's libel laws are highlighted in the really cool documentary, McLibel. You can watch the whole thing on Google Video:

http://video.google.com/videoplay?docid=547901963081075342#

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2. gyges on December 22, 2009 12:05 PM writes...

According to a report in the Guardian:

"Thomsen's lawyer, Andrew Stephenson, said his client's defence would be that the presentation and article were covered by qualified privilege, which can protect freedom of speech."

Does anyone know why he's running the defence of qualified privilege rather than justification?

I get the impression that there's more here than meets the eye; as yet, it isn't clear what.

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3. dearieme on December 22, 2009 12:27 PM writes...

"The UK's libel laws..": they are England's, Sir, not the UK's.

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4. Hap on December 22, 2009 12:45 PM writes...

1) Are libel laws different in different parts of the UK?

2) Did someone at GE Healthcare actually think this over before they filed the suit? Because if other regulatory authorities have already evaluated the claims and followed them themselves, all suing will do is attract attention both to them and their desperate desire to unthink unpleasant facts. And, as everyone knows (well, at least those in Dr. Rath's circle), the ability to unthink unpleasant realities is the key to profitable health care. (Not effective health care, or health care by people possessing a functioning conscience, however.)

Maybe GE's on to something.

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5. FormerMolecModeler on December 22, 2009 12:57 PM writes...

Truth is an absolute defense to libel or slander. I think that is the case in the UK as well. Doesn't sound like this is cut and dry.

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6. Dynastar on December 22, 2009 1:12 PM writes...

The point of these lawsuits isn't necessarily to win but to financially ruin the defendant and scare others who might think of doing such a thing. Mr Singh's defense has already run to six figures.

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7. MTK on December 22, 2009 1:25 PM writes...

I have no clue about UK law, or any other country for that matter, but I don't get this at all.

Beyond just the ethical and scientific reasons not to do this, there would seem to be real business reasons not to do so.

Even if GE Healthcare is "successful" in their lawsuit, if the association of nephrogenic systemic fibrosis is confirmed by other researchers, don't they open themselves up for far more damaging lawsuits in the future? From a risk assessment standpoint this doesn't seem to add up.

Maybe there is more to the story.

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8. Hap on December 22, 2009 1:58 PM writes...

But, if truth is an absolute defense, but the case isn't cut and dry, then GE would have to believe that Thomsen has misrepresented or falsified his work, and that his work is the primary evidence that various authorities have to restrict the use of Omniscan or to warn of problems with it. While the first could happen (sigh), the second seems harder to believe, unless authorities are relying of a tangle of references, all of which point back to Thomsen's work. (I don't know how things would work out if Thomsen had simply misinterpreted his evidence, and that evidence was the main reason Omniscan was limited - if he hadn't published with malice, then it would seem as if the regulatory agencies and not Thomsen would be to blame.)

In that case, wouldn't simply publishing evidence of Thomsen's malfeasance (if he had committed any) been a better idea? If the original publishers and other review had more or less confirmed the errors/fraud, then GE would have a much more secure case for a libel suit and the cloud around their imaging agent would have been dissipated. At minimum, they might have provided enough doubt to make people look carefully at their agents without abrogating the process of acquiring and publishing evidence. (Unless that's what they are intending to do, in fact.)

If he has evidence of truth, couldn't Thomsen turn it over to lawyers on contingency, since they could expect all of their fees (and some bonus damages as well) to be paid once GE finishes embarrassing themselves? That would make GE's persistence counterproductive, and would prevent them from silencing legitimate evidence.

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9. alig on December 22, 2009 1:59 PM writes...

In England, if you are the defendent in a libel suit, you must prove that your statement is true. In the US, the plantiff must prove that your statement is false. The defendent's burden is significantly higher in England.

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10. DerekF on December 22, 2009 2:18 PM writes...

I understand that, regrettably, truth is not an absolute defense to libel or slander in England, unlike the US. Between that and the procedural advantages mentioned by earlier posters for the person claiming to have been libeled, being sued for libel in England is no fun, even if you would think that Dr. Thomsen ought to win in a walk.

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11. Hap on December 22, 2009 2:22 PM writes...

So, if some moronic fundamentalist Christian gets a lawyer and sues Richard Dawkins in England for claiming that God doesn't exist (as a deity rather than as a thought/belief), they could actually win? Isn't that the reductio ad absurdum of an entire legal system?

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12. Petros on December 22, 2009 2:49 PM writes...

This is just the latest in a string of libel cases reflecting the use of the UK for libel tourism. And the judge who presides over nearly of these cases seems to exacerbate the issue. And the libel law have long been (ab)used by dubious business to stop the public finding out about their dealings, e.g Robert Maxwell founder of Pergamon (the original Tet Letts publishers)

Roman Polanski recently sued but was allowed to give evidence by videolink since he would have been sent back to the US if he landed in the UK!

With regard to Hap's question. The legal system in Scotland is different from that in England and Wales. although I don't know whether the libel laws are different.

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13. Lucifer on December 22, 2009 3:10 PM writes...

Is GE nuts? Their actions will get that issue far more attention.

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14. researchfella on December 22, 2009 3:48 PM writes...

Careful, Derek. You might be the next person to be sued by GE, for the defamatory comments on your blog.

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15. qetzal on December 22, 2009 4:04 PM writes...

When I first heard of this, it was on the WSJ Health Blog, which said:

GE Healthcare told the Times that the presentation was defamatory because it accused the company of suppressing information and marketing the drug when it was aware of possible problems, according to the article.

If Thomsen really did accuse GE of suppressing information, I could see some justification for the suit. (Assuming Thomsen couldn't back up such an accusation, of course.)

However, the link in Derek's post goes a little more in depth:

GE Healthcare said this weekend it believed the presentation was defamatory because it accused the firm of suppressing information and marketing its product when it was aware of possible problems.

Last week, however, a spokeswoman was unable to highlight any part of Thomsen’s presentation in which this allegation was made. The writ says the defamation may have been “by way of innuendo”.

From that, it sounds unlikely that Thomsen made any overt accusations. In which case, I too hope Thomsen prevails, and then I hope he countersues GE for defaming him, and wins big.

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16. dearieme on December 22, 2009 4:33 PM writes...

"1) Are libel laws different in different parts of the UK?" Virtually all laws are, except insofar as a big effort is made to keep commercial law and tax law nearly identical. England has a Common Law system, Scotland its own variety of Roman Law.

Permalink to Comment

17. gyges on December 22, 2009 4:58 PM writes...

@quetzal

"...unlikely that Thomsen made any overt accusations"

It is still possible to be defamatory through innuendo. It would be helpful if the particulars of the case were available. Thomsen should have them ... has he got a scanner?

Permalink to Comment

18. S Silverstein on December 22, 2009 8:14 PM writes...

gyges wrote: "It would be helpful if the particulars of the case were available. Thomsen should have them ... has he got a scanner?"

I emailed Prof. Thomsen and asked if a copy of the docket were available. I will blog on it at Healthcare Renewal if I can obtain it, or more specifics than appears in the press.

BTW would it be defamatory for me to recall the Radiological Society of North America (RSNA) meeting in Chicago, 1999, when GE had a large booth and huge banner proclaiming themselves "Leaders in Radiology Informatics?"

Nobody present knew what the term "informatics" meant when I asked them, except perhaps for one technician who replied that it meant "something about the computers hooked to their x-ray machines."

-- SS

Permalink to Comment

19. will on December 22, 2009 10:00 PM writes...

I don't know about libel law in England, but this suit could be an even bigger headache for GE - if Thomsen is allowed to take discovery of internal GE data and marketing strategy in his defense of truth.

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20. gyges on December 23, 2009 3:26 AM writes...

More details.

The Times article explains that the author of the article is Jeff Gerth and the story is based on his story, GE Suit Hushes Scientist Critical of Omniscan. Within this article, there is a link to GE v Thomsen a fairly large pdf document (135 pages) giving the slide presentation and the particulars of the claim.

While here is a link to an HTML friendly document.

Close reading of this document should give us a greater understanding ... and may shed a poor light on Thomsen?

Permalink to Comment

21. A Nonny Mouse on December 23, 2009 5:14 AM writes...

Having heard the chap speak on BBC radio 4's "Today" programme, it appears that the justification is that his presentation was put onto the internet for a couple of days and that it could have been viewed by people in the USA (though it appears that there were only 6-7 viewings of the site from there).

Even though it was promptly removed GE issued the law suit (though sometime later!).

Permalink to Comment

22. A Nonny Mouse on December 23, 2009 5:46 AM writes...

Re: The above post

Sorry, this is a different, but similarly related case. Apart from the fact that this is obviously happening too much, please ignore the above!

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23. Lynne Gailey from GE Healthcare on December 23, 2009 7:02 AM writes...

GE Healthcare has promoted a vigorous scientific debate about the safety of Gadolinium Based Contrast Agents (GBCAs), including Omniscanâ„¢ and we reject any suggestion to the contrary.

Like the many other scientists who have contributed to this discussion, Dr. Henrik Thomsen is entitled to express any and all honestly-held beliefs so long as his views as expressed are not knowingly indifferent to the true state of affairs.

GE Healthcare encourages such scientific debate but the imperative of a robust debate about the safety of gadolinium-based contrast agents does not license Dr. Thomsen to make knowingly false and inaccurate statements about GE Healthcare or its products. GE Healthcare initiated the lawsuit because, despite repeated efforts by GE Healthcare to engage in a constructive dialogue with Dr. Thomsen, he persisted in making false accusations that the company had deliberately concealed and suppressed information from regulatory authorities in relation to its contrast agent, Omniscan. This action is not about the science, it is about the inaccurate statements that Dr Thomsen has made about the company.

GE Healthcare has cooperated fully and actively promoted a robust evaluation of the safety of GBCAs in Europe, the United States and elsewhere based on the evidence and the science. We welcome the continuation of a principled dialogue about the safety of GBCAs.

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24. Thomas McEntee on December 23, 2009 8:21 AM writes...

Goodness! While industry writ large certainly has offered more than its fair share of denials, lies, and obfuscations dealing with human health and the environment over the years, I am impressed that Lynne Gailey from GE Healthcare has offered a rebuttal in this forum. I know nothing of the particulars of this topic or the reliability of the parties' assertions but as several readers noted, there are at least two sides to this story. Sounds like some high-level scientific dignitary ought to invite the two to come over, have a pint or two, and talk it through...

Permalink to Comment

25. fromsgc on December 23, 2009 8:41 AM writes...

GE post exactly the same official text on all blogs/forums that mentioned the topic.

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26. Thomas McEntee on December 23, 2009 9:16 AM writes...

Well, so much for the idea of a corporate response thoughtfully tailored for this forum... I half-figured that their automated news scrapers picked up Derek's story and that Lynne's reply was what #24 seems to confirm. False hope dashed again!

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27. alig on December 23, 2009 9:39 AM writes...

"So, if some moronic fundamentalist Christian gets a lawyer and sues Richard Dawkins in England for claiming that God doesn't exist (as a deity rather than as a thought/belief), they could actually win?"

There is nothing defamatory in claiming that God does not exist (except perhaps to God, and I don't think He will bother to sue in English courts) so the truth (or falseness) of that statement is irrelevant to whether it is libel.

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28. MattF on December 23, 2009 9:43 AM writes...

Gosh. And what happens if/when someone with kidney disease now sues GE Healthcare in a US court for their post-NMR health problems? If I was a US radiologist, I'd be giving my techs very specific instructions about the suppliers of NMR contrast media.

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29. Vader on December 23, 2009 11:43 AM writes...

Every legitimate field of scientific inquiry has its crusaders, whose targets naturally try to depict them as twits.

Unfortunately, every such field also has its twits, who try to depict themselves as crusaders.

I have no idea if Thomsen is a crusader or just a twit. And I suspect no one else here has a very good idea either.

A story worth following either way.

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30. S Silverstein on December 23, 2009 11:55 AM writes...

Re: my #18

I received a reply from Dr. Thomsen

The documents including lawsuit docket are at http://documents.propublica.org/ge-v-thomsen-a-british-libel-case

Permalink to Comment

31. startup on December 23, 2009 12:54 PM writes...

#22. So GE is concerned about its perception by public? Good. Because comparisons with Irving's libel suit are surely coming.

Permalink to Comment

32. S Silverstein on December 23, 2009 1:31 PM writes...

On page 19 of "GE's response to Thomsen's defence" at http://documents.propublica.org/ge-v-thomsen-a-british-libel-case it states:

... (i) In fact, the literature referred' to pre-dated the' discovery of NSF, which was first reported in 2000; drawing on a case history from 1997. The 1993 and 1994 studies were not widely known, not generally understood or considered to have significance as predicting potential adverse effects in humans ...

GE then claims the articles were only selectively quoted, although from the slide deck, I think there was reasonable cause for concern.

My question is, was GE itself aware of these articles at any time before Dr. Thomsen referenced them in his presentations?

Permalink to Comment

33. cynical1 on December 23, 2009 2:07 PM writes...

According to The International Society for Magnetic Resonance in Medicine, Omniscan has been reported to have a higher incidence of nephrogenic systemic fibrosis than the other Gd-contrast agents but as mentioned, they all carry the warning. For you chemists, the current hypothesis is that the uncharged, acyclic Gd chelators (like OptiMARK and Omniscan) are more likely to release free Gd3+ than their tetraazacrown derived and/or charged relatives and the unchelated metal causes the toxicity. I have heard, but can not confirm, that the charged agents are more painful during the infusion than their neutral counterparts (from osmotic pressure?). Perhaps, since Omniscan is neutral, it is better tolerated than the other agents. Dunno. However, I'd love to see a chart with equilibrium constants of all the contrast agents with Gd along with their incidence of nephrogenic systemic fibrosis. That seems like it might be a clinically relevant thing to look at.

As for the lawsuit, that just seems dumb to me but what do I know. I wonder if my former employer could sue me because I've said it was a crappy place to work, albeit not at an ACS meeting during a presentation.

Permalink to Comment

34. anon on December 23, 2009 4:53 PM writes...

cynical1 writes "As for the lawsuit, that just seems dumb to me but what do I know."

What do you know? More than you think you know.

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35. Morten G on December 23, 2009 7:01 PM writes...

Funny thing is the debate in Denmark was whether it was irresponsible not to stop the use of Omniscan when the suspicion that it caused NSF first arose instead of waiting until the statistics had been run. But a lot of people died from this and those who didn't are severely disabled, disfigured, and in constant pain. I can see why Thomsen would get agitated if he thought GE Health suspected problems.

On another note, I once did some TA'ing that involved MRIs. Considering all the things you can do with an MRI machine it seemed to me then that contrast agents could likely be an unnecessary habit carried over from x-ray angiograms. Doctors are very much creatures of habit - they are not likely to spend time developing new diagnostics if they have one that they like fine.

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36. MR physicist on December 23, 2009 8:17 PM writes...

@Morten G
I think contrast agents are not likely to disappear since they do add diagnostic value to an MRI in many cases. In fact, lots of people including me are being kept busy to widen the applicability of some (e.g. for dynamic contrast enhanced MRI). We'd really like to see you chemists come up with some more specific agents if possible. Don't let NSF scare you.

To get back on the main topic: wonder whether I should consider lobbying my employer on future purchasing decisions not to buy scanners from GE ...

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37. The Pharmacoepidemiologist on December 24, 2009 12:29 AM writes...

As a pharmacoepidemiologist, the data implicating some of the gandolinium contrast agents (including GE's product) is pretty much overwhelming. The epidemiology is pretty tight, and there have been a number of reviews which have come to this conclusion during the past 3-4 years (you can find them on PubMed pretty easily). That GE thinks it can prevail in a libel suit borders on idiocy and lots of denial. Maybe it thinks it improves its legal situation in the US? I can't imagine any other reason for undertaking this suit. And for those who think there's more here than meets the eye, take a look at the review papers and then the original reports of studies and come to your own conclusion. I think you will see just how conclusive the case is for the causal inference.

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38. gyges on December 24, 2009 5:00 AM writes...

It would be interesting to hear a response from experts regarding Silverstein's point @32.

Also, does anyone know why Thomsen's employer's aren't being sued due to their vicarious liability?

Does anyone know whether or not Thomsen sought any legal advice before publishing? If not, why not?

I don't think that this is as clear cut as 'big pharma' tries to suppress truth; which is the impression I get from reading news reports.

Permalink to Comment

39. Hap on December 29, 2009 4:17 PM writes...

It might be libelous on his church, though, and in that case, if it chose to sue, proving a negative in an (almost) infinite space would be necessary for Prof. Dawkins to defend against the suit.

It still seems like a negation of sane law.

Permalink to Comment

40. sgcox on April 1, 2010 6:05 AM writes...

some good news from libel front at last!

http://news.bbc.co.uk/1/hi/uk/8598472.stm

Permalink to Comment

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